Signifor

For treatment of Cushing’s disease in adults for whom surgery has not worked well enough or who cannot have surgery.

For treatment of acromegaly in adults for whom surgery has not worked well enough or who cannot have surgery.

Indications and Usage

SIGNIFOR LAR (pasireotide) is used to help treat:

Acromegaly in adults for whom surgery has not worked well enough or who cannot have surgery.

Cushing’s disease in adults for whom surgery has not worked well enough or who cannot have surgery.

Important Safety Information

High blood sugar (hyperglycemia) and diabetes: SIGNIFOR LAR (pasireotide) can cause serious side effects such as high blood sugar (hyperglycemia). Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR (pasireotide) and while you receive it. Tell your healthcare provider if you have any of these symptoms: feel very thirsty, urinate more than usual, increased appetite with weight loss, and/or tiredness. If you get hyperglycemia, your healthcare provider may give you medicine to lower your blood sugar and/or change your dose of SIGNIFOR LAR (pasireotide) or advise you to stop receiving it.

Indications and Usage

SIGNIFOR LAR (pasireotide) is used to help treat:

Acromegaly in adults for whom surgery has not worked well enough or who cannot have surgery.

Cushing’s disease in adults for whom surgery has not worked well enough or who cannot have surgery.

Important Safety Information

High blood sugar (hyperglycemia) and diabetes: SIGNIFOR LAR (pasireotide) can cause serious side effects such as high blood sugar (hyperglycemia). Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR (pasireotide) and while you receive it. Tell your healthcare provider if you have any of these symptoms: feel very thirsty, urinate more than usual, increased appetite with weight loss, and/or tiredness. If you get hyperglycemia, your healthcare provider may give you medicine to lower your blood sugar and/or change your dose of SIGNIFOR LAR (pasireotide) or advise you to stop receiving it.

Slow heart rate (bradycardia) and changes in the electrical system of your heart (QT Prolongation): SIGNIFOR LAR (pasireotide) can cause your heart to beat slower, which can cause you to feel weak, dizzy, or even faint. People who have, or have had, heart problems, are at greater risk for bradycardia. Abnormal heart beats, weakness, dizziness, and fainting spells may occur due to problems with the electrical system of the heart and can be serious. Call your doctor right away if you experience such spells.

Gallstones (cholelithiasis) and complications that can happen if you have gallstones: Gallstones are a serious but common side effect of SIGNIFOR LAR (pasireotide). Your healthcare provider should do a test (ultrasound) to check your gall bladder before and during your treatment.

Most common side effects of SIGNIFOR LAR (pasireotide) include: diarrhea; headache; stomach-area pain; hair loss; stuffy nose and sore throat; low blood sugar; limb swelling; loss of appetite; nausea; increase in the level of the enzyme in your blood called creatine phosphokinase (CPK); tiredness; stomach bloating, high blood pressure; back pain. These are not all the possible side effects of SIGNIFOR LAR (pasireotide). For more information, ask your healthcare provider.

To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before Taking SIGNIFOR LAR (pasireotide) patients should tell their doctor about all of their medications. SIGNIFOR LAR (pasireotide) may affect the way other medicines work, and other medicines may affect how SIGNIFOR LAR (pasireotide) works. Especially tell your healthcare provider if you take medicines to control your heart beat (antiarrhythmics), medicines to control your blood pressure (beta-blockers or calcium channel blockers), medicines to control the potassium and magnesium (electrolytes) levels in your body, medicines that may affect the way the electrical system of your heart works (QT prolongation), cyclosporine, and bromocriptine.

Use in Specific Populations:

Females and Males of Reproductive Potential: Treatment with SIGNIFOR LAR (pasireotide) may result in improved fertility and the possibility of unplanned pregnancy in females who have not gone through menopause. Talk to your healthcare provider about birth control methods that may be right for you during treatment.

It is not known if SIGNIFOR LAR (pasireotide) is safe and effective for use in children.

Disclaimer

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